Setting-up a clinical trial: Some methodological recommendations

IF 0.6 Q4 PSYCHOLOGY
Desirée Colombo , Pietro Cipresso , Elisa Pedroli , Giuseppe Riva
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引用次数: 0

Abstract

Well-designed clinical trials are the gold standard for evidence-based research and for the assessment of the effectiveness of a clinical intervention. Methodological guidelines are available from various sources, such as textbook, funding applications and institutional guidelines. Nevertheless, a high number of published trials still lack methodological rigor, decreasing their utility, quality and scientific validity. In this article, we aim at providing some methodological recommendations for the development and report of a clinical trial, including the definition and recruitment of the sample, the basic study designs, randomization, blindness, data analysis and data report. Finally, we will discuss some of the most important ethical issues.

建立临床试验:一些方法学建议
设计良好的临床试验是循证研究和评估临床干预有效性的黄金标准。方法指南可从各种来源获得,例如教科书、资助申请和机构指南。然而,大量已发表的试验仍然缺乏方法上的严谨性,降低了它们的效用、质量和科学有效性。在本文中,我们旨在为临床试验的开发和报告提供一些方法学建议,包括样本的定义和招募,基本研究设计,随机化,盲性,数据分析和数据报告。最后,我们将讨论一些最重要的伦理问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
0.80
自引率
40.00%
发文量
21
期刊介绍: The Anuario de Psicología, one of Spain"s most important general psychology journals, is published by the Faculty of Psychology of the University of Barcelona. It appears three times a year. The Anuario combines continuity with the past with a strong commitment to the present and the future. The journal is broad-ranging, interdisciplinary, and innovative. The Anuario publishes research reports and applied studies in all fields of psychology. We also accept theorical, epistemological studies, organize dossiers on topical themes, and hold debates on controversial subjects deriving from a central article.
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